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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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EU Notified Bodies Update Code of Conduct

The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms.

First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified Bodies should follow during CE Marking audits and certifications; another update, version 4.0, is already planned for the near future.

Key changes

Among the changes in version 3.2 of the code are requirements for compliance with specific EU Medical Device Directive mandates rather than core principles; adjusted frequency requirements for unannounced audits of high-risk devices; and changes to sampling requirements of technical file reviews to apply only to Class IIa and IIb devices.

Team-NB describes these changes as minor, but also indicates more important issues to be addressed in version 4.0 of the code, including minimum review timeframes for technical files, auditor qualifications and developing criteria for technical reviews and training.

Minimal dropout rate

Following implementation of the Code of Conduct, European medical device market observers and participants questioned whether new requirements would shake up the Notified Body sector.

According to information Team-NB included in its announcement of the code’s latest version, there has been a slight drop in the number of the association’s members since 2012. Since plans for the Code of Conduct were first announced, Team-NB membership fell from 35 in 2012 to 29 in 2013; that number fell again to 26 in 2014.